Nasopharyngoscope (Flexible Or Rigid)
FDA product code EOB · Class II (moderate risk) · 21 CFR 874.4760 · Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
162510(k) clearances
0PMA approvals
8recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 28
- Vision-Sciences, Inc. 15
- Olympus Medical Systems Corp. 8
- Acclarent, Inc. 4
- Pentax of America, Inc. 4
- 3nt Medical , Ltd. 3
- Olympus America, Inc. 3
- Optim, LLC 3
- Schoelly Fiberoptic GmbH 3
- Xomed-Treace, Inc. 3
- Ambu A/S 3
- The Olympus Optical Co. 3
- Pentax Precision Instrument Corp. 2
- Entellus Medical, Inc. 2
- Medrobotics Corporation 2
- J. Jamner Surgical Instruments, Inc. 2
- Jedmed Instrument Co. 2
- Pentax Medical Company 2
- Xomed, Inc. 2
- Richard Wolf Medical Instruments Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
| K222587 | PatCom Distal Chip EndoscopeEOB · Traditional | H&A Mui Enterprises, Inc. | 07/28/2023SE |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video MonitorEOB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 06/14/2023SE |
| K221660 | Rhino-Laryngofiberscope Olympus Enf Type-XpEOB · Traditional | Olympus Medical Systems Corp. | 12/28/2022SE |
| K221581 | Single-Use Flexible RhinolaryngoscopeEOB · Traditional | Hunan Vathin Medical Instrument Co., Ltd. | 11/18/2022SE |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT…EOB · Traditional | Pentax of America, Inc. | 11/16/2022SE |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3EOB · Traditional | Olympus Medical Systems Corp. | 09/19/2022SE |
| K214050 | ENT Nasopharyngoscope and AccessoriesEOB · Traditional | Medimaging Integrated Solution, Inc (Miis) | 07/01/2022SE |
| K220004 | Zsquare ENT-Flex EndoscopeEOB · Traditional | Zsquare, Ltd. | 06/14/2022SE |
| K202727 | Peregrine Endoscopy SystemEOB · Traditional | 3nt Medical , Ltd. | 07/23/2021SE |
| K200609 | ENTity WiFi Video Nasopharyngoscope SystemEOB · Traditional | Optim, LLC | 01/13/2021SE |
| K200740 | HD Video Rhino LaryngoscopeEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/11/2020SE |
| K192305 | Colibri Endoscopy SystemEOB · Special | 3nt Medical , Ltd. | 02/27/2020SE |
| K192090 | CMOS Video Rhino-Laryngoscope SSUEOB · Traditional | Karl Storz SE & CO. KG | 01/27/2020SE |
| K191102 | Precision S 4K SinuscopeEOB · Traditional | Stryker | 09/06/2019SE |
| K183416 | Rhino-Laryngo Videoscope Olympus ENF-VT3EOB · Traditional | Olympus Medical Systems Corp. | 09/06/2019SE |
| K190972 | Ambu aScope 4 RhinoLaryngo InterventionEOB · Traditional | Ambu A/S | 07/12/2019SE |
| K183691 | PENTAX Medical ENT Video Imaging SystemEOB · Special | Pentax of America, Inc. | 06/12/2019SE |
| K191080 | Ambu aScope 4 RhinoLaryngo SlimEOB · Special | Ambu A/S | 05/22/2019SE |
| K182186 | CMOS Video-Rhino-Laryngoscope SystemEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/2019SE |
| K182102 | Rhino-Laryngo Videoscope Olympus ENF-VH2, Rhino-Laryngo Videoscope Olympus ENF-V4EOB · Traditional | Olympus Medical Systems Corp. | 02/06/2019SE |
| K182846 | PENTAX Medical EPK-3000 Video Imaging SystemEOB · Special | Pentax of America, Inc. | 01/09/2019SE |
| K181286 | Ambu aScope RLS SlimEOB · Traditional | Ambu A/S | 11/30/2018SE |
| K181240 | Rhino-Laryngo Fiberscope Olympus ENF-GP2EOB · Traditional | Olympus Medical Systems Corp. | 10/04/2018SE |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope SolutionEOB · Traditional | Pentax Medical | 07/18/2018SE |
| K173855 | Sharpsite AC Rigid EndsocopeEOB · Traditional | Medtronic Xomed, Inc. | 04/20/2018SE |
| K172156 | PENTAX Medical EPK-3000 Video Imaging SystemEOB · Traditional | Pentax Medical | 04/05/2018SE |
| K171402 | KARL STORZ Slim NasopharyngolaryngoscopeEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/02/2018SE |
| K170453 | Medrobotics Flex Robotic SystemEOB · Traditional | Medrobotics Corporation | 10/19/2017SE |
| K161298 | ShenDa SinuscopeEOB · Traditional | Shenyang Shenda Endoscope Co., Ltd. | 08/25/2017SE |
| K170285 | AED SinuscopeEOB · Traditional | National Advanced Endoscopy Devices, Inc. | 08/01/2017SE |
| K162151 | PENTAX Medical ENT Video Imaging SystemEOB · Traditional | Pentax of America, Inc. | 04/20/2017SE |
| K162410 | TIPCAM 1S 3D SystemEOB · Traditional | Karl Storz Endoscopy America, Inc. | 03/02/2017SE |
| K162916 | 3NT endoscopy systemEOB · Traditional | 3nt Medical , Ltd. | 02/24/2017SE |
| K153701 | ULYSS Multi View SinuscopeEOB · Traditional | Sopro-Comeg GmbH | 09/09/2016SE |
| K153009 | ULTRA TelescopesEOB · Traditional | Olympus Winter & Ibe GmbH | 04/05/2016SE |
| K152531 | InstaClear Lens CleanerEOB · Traditional | Gyrus Acmi, Inc. | 01/15/2016SE |
| K150776 | Medrobotics Flex SystemEOB · Traditional | Medrobotics Corporation | 07/17/2015SE |
| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | Schoelly Fiberoptic GmbH | 03/04/2015SE |
| K142249 | Schoelly SinuscopeEOB · Traditional | Schoelly Fiberoptic GmbH | 01/27/2015SE |
| K131323 | Ecleris SinuscopeEOB · Traditional | Ecleris USA | 06/09/2014SE |
| K132433 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Traditional | Acclarent, Inc. | 04/24/2014SE |
| K132009 | Cmos Video Nasopharyngoscope SystemEOB · Traditional | Schoelly Fiberoptic GmbH | 04/09/2014SE |
| K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CMEOB · Special | KARL STORZ Endoscopy-America, Inc. | 06/28/2012SE |
| K110097 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Special | Acclarent, Inc. | 05/27/2011SE |
| K102733 | Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences…EOB · Traditional | Vision-Sciences, Inc. | 05/18/2011SE |
| K102366 | Finess EndoscopeEOB · Traditional | Entellus Medical, Inc. | 02/15/2011SE |
| K100577 | Acclarent Cyclops Multi-Angle EndoscopeEOB · Traditional | Acclarent, Inc. | 01/06/2011SE |
| K100125 | Vision Sciences Flexible ENT ScopeEOB · Special | Vision-Sciences, Inc. | 02/25/2010SE |
| K083553 | Naso-Laryngo-PharyngoscopeEOB · Special | Schoelly Imaging, Inc. | 01/16/2009SE |
| K080740 | Clearview Endoscope CoverEOB · Traditional | Invotec International, Inc. | 12/31/2008SE |
| K082667 | Visionsense Stereoscopic Vision System (VS System)EOB · Traditional | Visionsense, Ltd. | 10/30/2008SE |
| K082569 | Entellus Medical Flexible Endoscope and EyepieceEOB · Traditional | Entellus Medical, Inc. | 09/18/2008SE |
| K080622 | Entity Nasoview LED Nasopharyngoscope, Model 006105EOB · Special | Optim, Inc. | 04/02/2008SE |
| K072387 | Karl Storz Video Rhino-Laryngscope System, Model 11101 SeriesEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/13/2007SE |
| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System…EOB · Special | Vision-Sciences, Inc. | 08/29/2007SE |
| K070580 | Nasopharyngoscope, BronchoscopeEOB · Traditional | Xion GmbH | 06/13/2007SE |
| K070752 | Ksea Miniature Endoscope, Model 11565EOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/01/2007SE |
| K063078 | MicroendoscopeEOB · Traditional | Acclarent, Inc. | 10/24/2006SE |
| K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…EOB · Traditional | Rtc Inc.-Memcath Technologies, LLC | 09/06/2006SE |
| K052452 | Visera Rhino-Laryngovideoscope Olympus Enf Type VTEOB · Traditional | Olympus Medical Systems Corporation | 09/21/2005SE |
| K050972 | Vision-Sciences ENT-3000 ScopeEOB · Special | Vision-Sciences, Inc. | 04/29/2005SE |
| K040984 | Vision Sciences Model ENT-2000V Flexible Nasopharyngo-LaryngoscopeEOB · Special | Vision-Sciences, Inc. | 04/27/2004SE |
| K032822 | Asap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00…EOB · Traditional | Asap Endoscopic Products GmbH | 01/08/2004SE |
| K030857 | Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic…EOB · Traditional | Mahe Intl., Inc. | 10/16/2003SE |
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type VEOB · Traditional | Olympus Optical Co., Ltd. | 07/24/2003SE |
| K031790 | Slide-On Endosheath System for Sensory TestingEOB · Traditional | Vision-Sciences, Inc. | 07/02/2003SE |
| K030572 | Henke Sass Wolf of America NasopharyngoscopeEOB · Traditional | Henke Sass Wolf of America, Inc. | 04/01/2003SE |
| K023004 | Lfre Indirect LaryngoscopeEOB · Traditional | Astralite Corp. | 01/28/2003SE |
| K024095 | Modification to Vision Sciences Endosheath SystemEOB · Special | Vision-Sciences, Inc. | 01/09/2003SE |
| K012543 | Vision Sciences Endosheath SystemEOB · Traditional | Vision-Sciences, Inc. | 07/15/2002SE |
| K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type VEOB · Special | Olympus America, Inc. | 05/01/2002SE |
| K020599 | MTP Clearvision Disposable Tubing SetEOB · Traditional | Mtp Medical Technical Promotion GmbH | 03/13/2002SE |
| K013838 | Ksea Clearvision Lens Irrigation SystemEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/16/2002SE |
| K013591 | Xenf-Tp Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentEOB · Traditional | Olympus Optical Co., Ltd. | 12/26/2001SE |
| K011869 | Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentEOB · Traditional | The Olympus Optical Co. | 07/25/2001SE |
| K003830 | ENT EndoscopesEOB · Traditional | Global Endoscopy, Inc. | 04/09/2001SE |
| K002214 | Sinuscope and BaccessoriesEOB · Traditional | Pollux Endoscopy, Inc. | 11/21/2000SE |
| K002700 | Ksea Unimat 12EOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/18/2000SE |
| K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeEOB · Traditional | Richard Wolf Medical Instruments Corp. | 09/24/1999SE |
| K991560 | Naso-Laryngo-PharyngoscopeEOB · Traditional | Fiber Imaging Technologies, Inc. | 07/13/1999SE |
| K990354 | EndosheathEOB · Special | Vision-Sciences, Inc. | 03/31/1999SE |
| K990213 | Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear…EOB · Special | Gyrus Ent LLC | 02/02/1999SE |
| K984369 | Dci EndoscopeEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/29/1999SE |
| K983123 | Poc ENT Endoscope - SinuscopeEOB · Traditional | Precision Optics Corp. | 09/25/1998SE |
| K982594 | Endo-Scrub/Endo-Scrub 2EOB · Traditional | Xomed, Inc. | 08/27/1998SE |
| K981751 | Sinuscope and AccessoriesEOB · Traditional | Henke Sass Wolf of America, Inc. | 08/13/1998SE |
| K981458 | Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and…EOB · Traditional | Karl Storz Endoscopy | 05/20/1998SE |
| K972450 | Flextip GrasperEOB · Traditional | Endius, Inc. | 11/21/1997SE |
| K971375 | Greatbatch Scientific MR Compatible SinuscopeEOB · Traditional | Wilson Greatbatch Technologies, Inc. | 10/31/1997SE |
| K972855 | Karl Storz Contact Nasal Micro-EndoscopesEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/08/1997SE |
| K971995 | Medivision SinoscopeEOB · Traditional | Medivision Scope Service Center, Inc. | 06/26/1997SE |
| K965233 | Sharpsite AcEOB · Traditional | Xomed, Inc. | 04/04/1997SE |
| K970247 | Smith & Nephew Images Arthroscope/Ent EndoscopeEOB · Traditional | Smith & Nephew, Inc. | 03/21/1997SE |
| K962116 | Galileo EndoscopesEOB · Traditional | Galileo Electro-Optics Corp. | 11/27/1996SE |
| K963757 | Irrigation/Suction Handle and SheathEOB · Traditional | Richard Wolf Medical Instruments Corp. | 11/26/1996SE |
| K963426 | Karl Storz Contact Micro-LaryngoscopesEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/07/1996SE |
| K962255 | Clarus Murphypen ENDOSCOPE(2127-XXX)EOB · Traditional | Clarus Medical Systems, Inc. | 09/11/1996SE |
| K962898 | Ksea Unimat PlusEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/27/1996SE |
| K962396 | Ksea Bipolar Goagulating ForcepsEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/27/1996SE |
| K950809 | Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-LaryngoscopesEOB · Traditional | Vision-Sciences, Inc. | 08/05/1996SE |
| K961591 | Disposable Endosheath for E-F100 Flexible NasopharyngoscopeEOB · Traditional | Vision-Sciences, Inc. | 07/02/1996SE |
| K960876 | Five Star BronchoscopeEOB · Traditional | Five Star Medical, Inc. | 05/08/1996SE |
| K955560 | Trebay Scope Irrigated Clearing SleeveEOB · Traditional | Trebay Medical Corp. | 12/22/1995SE |
| K942265 | Flexible Nasopharyngo-Laryngoscope and EndosheathEOB · Traditional | Vision-Sciences, Inc. | 12/22/1995SE |
| K953771 | Operating Laryngoscopes & Accessories Forceps, ProtectorsEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/22/1995SE |
| K954348 | Glanz Carcinoma Gauge, KseaEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/15/1995SE |
| K954336 | Endo-Bend Grasper (114.3 MM Shaft-Sterile)EOB · Traditional | Aust & Taylor Medical Corp. | 11/13/1995SE |
| K953888 | Telescope 4MM, 2.7MM Diam. Wide Angle 0', 30', 70', 4MM, Diam, 30' Work, L 14CM…EOB · Traditional | Vista Medical Technologies, Inc. | 10/07/1995SE |
| K940317 | SinuscopeEOB · Traditional | Stephen Chakoff, Inc. | 05/24/1995SE |
| K951249 | Citation SinuscopeEOB · Traditional | Citation Medical Corp. | 04/10/1995SE |
| K951196 | FNL-10P, Fiber NasoparhyngoscopeEOB · Traditional | Pentax Precision Instrument Corp. | 04/07/1995SE |
| K951201 | Karl Storz Nasal,, Tonsil, Ear, Laryngeal SnareEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/06/1995SE |
| K940028 | Endoscope SheathEOB · Traditional | Xomed-Treace, Inc. | 03/24/1995SE |
| K945081 | Transtympanic EndoscopeEOB · Traditional | Endooptiks, Inc. | 03/06/1995SE |
| K950603 | Karl Storz Viscous Fluid Injection SetEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/27/1995SE |
| K950334 | Karl Storz Tele-ScrubEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/27/1995SE |
| K950338 | Karl Storz Rhino-Pharyngo-Laryngo-Fiberscope, Biopsy, Grasping ForcepsEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/24/1995SE |
| K944861 | Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar…EOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/21/1995SE |
| K946011 | Argus Sinus Endoscopy Instrument SystemEOB · Traditional | Argus Medical Co., Inc. | 02/17/1995SE |
| K946148 | Karl Stors Knives, Curettes, Hooks, NeedlesEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 02/09/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | Jedmed Instrument Co. | 02/07/1995SE |
| K944670 | Jarit Recommended Sinus InstrumentsEOB · Traditional | J. Jamner Surgical Instruments, Inc. | 02/02/1995SE |
| K944656 | Optus Sinuscopes and AccessoriesEOB · Traditional | Optus, Inc. | 01/26/1995SE |
| K945788 | Karl Storz Rigid Telescopes for ENT Endoscopic ProceduresEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/25/1995SE |
| K945381 | Nasopharyngoscopes, Bronchoscopes, Tracheoscp[Es and Esophagoscopes, Laryngoscopes…EOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/18/1995SE |
| K944072 | Olympus Nasal and Sinus EndoscopesEOB · Traditional | Olympus America, Inc. | 01/11/1995SE |
| K944797 | Karl Storz Insulated Cannulae, Suction TubesEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/22/1994SE |
| K944298 | Karl Storz Insulated ScissorsEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/22/1994SE |
| K944186 | SinuscopeEOB · Traditional | Stryker Endoscopy | 11/07/1994SE |
| K944296 | Karl Storz Optical Video Tongue DepressorEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/14/1994SE |
| K943665 | Nasal Endoscopy & Sinuscopy Hand InstrumentsEOB · Traditional | Olympus America, Inc. | 10/11/1994SE |
| K943816 | Trocars,Cannulae, SheathsEOB · Traditional | Karl Storz Endoskop GmbH | 08/24/1994SE |
| K943074 | Forceps, Punches, ScissorsEOB · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/02/1994SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | Xomed-Treace, Inc. | 07/18/1994SE |
| K941565 | Jarit Recommended Sinus InstrumentsEOB · Traditional | J. Jamner Surgical Instruments, Inc. | 05/16/1994SE |
| K936257 | Ultrathin Flexible Endoscope TAS-211/2.3EOB · Traditional | Mitsubishi Cable America, Inc. | 03/24/1994SE |
| K934422 | NasopharyngoscopeEOB · Traditional | Marks & Murase | 01/27/1994SE |
| K933105 | Xomed-Treace Rigid Rod Lens EndoscopeEOB · Traditional | Xomed-Treace, Inc. | 01/05/1994SE |
| K933247 | Protective Sheath for Flexible Nasophary/LarygnosEOB · Traditional | Vision-Sciences, Inc. | 11/22/1993SE |
| K932988 | Accessories for Endoscopes for Sinus SurgeryEOB · Traditional | Smith & Nephew Richards, Inc. | 07/26/1993SE |
| K930931 | Nasal/Paranasal EndoscopeEOB · Traditional | Storz Instrument Co. | 05/17/1993SE |
| K925421 | EndosheathEOB · Traditional | Vision-Sciences, Inc. | 01/15/1993SE |
| K921244 | Disposable Protective SheathEOB · Traditional | Vision-Sciences, Inc. | 10/06/1992SE |
| K920439 | Omega Oto Nasopharyngo-LaryngoscopeEOB · Traditional | Omega Universal Technologies, Ltd. | 09/04/1992SE |
| K921707 | Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2EOB · Traditional | Pentax Precision Instrument Corp. | 07/01/1992SE |
| K902683 | Scopescrubber(Tm)EOB · Traditional | Healthtek Microsurgical, Inc. | 10/31/1990SE |
| K900176 | ENT-2 Flexible Nasopharygno-LaryngoscopesEOB · Traditional | Machida, Inc. | 04/10/1990SE |
| K896297 | Flexible NasopharyngoscopeEOB · Traditional | Jedmed Instrument Co. | 01/26/1990SE |
| K895245 | Flexible Fiber-Optic NasopharyngoscopeEOB · Traditional | Optimed Technologies, Inc. | 11/17/1989SE |
| K882744 | Effner Illuminated Nasal Tracheostoma SpeculumEOB · Traditional | Effner, Inc. | 08/10/1988SE |
| K874215 | Endoscopes for Sinus SurgeryEOB · Traditional | Richards Medical Co., Inc. | 01/04/1988SE |
| K864821 | Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2EOB · Traditional | Reichert-Jung, Inc. | 02/10/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1888-2024 Class II | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans…Potential for distal end of the sheath to break off during a procedure. | Olympus Corporation of the Americas | 04/03/2024Open, Classified |
| Z-1368-2024 Class II | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and…Japanese IFU version had slightly different language and illustrations from the English IFU, which could… | Olympus Corporation of the Americas | 01/16/2024Open, Classified |
| Z-0688-2024 Class II | Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPEOlympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual… | Shirakawa Olympus Co., Ltd. | 12/04/2023Open, Classified |
| Z-1054-2022 Class II | 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. | Karl Storz Endoscopy | 04/01/2022Open, Classified |
| Z-2292-2020 Class II | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal…Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with… | Olympus Corporation of the Americas | 05/05/2020Terminated |
| Z-2074-2016 Class II | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-0929-2012 | Product is a lithium ion battery sold as both a stand-alone accessory, and as part of…Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential… | Vision-Sciences, Inc. | 12/27/2011Terminated |
| Z-0928-2012 | Product is a lithium ion battery charger sold as both a stand-alone accessory, and as…Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential… | Vision-Sciences, Inc. | 12/27/2011Terminated |